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[Federal Register Volume 89, Number 246 (Monday, December 23, 2024)]
[Proposed Rules]
[Pages 104486-104493]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-30401]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Chapter I

[EPA-HQ-OPPT-2024-0085; FRL-5398-06-OCSPP]
RIN 2070-AJ64

Lead Wheel Weights; Petition for Rulemaking Under the Toxic 
Substances Control Act (TSCA); Decision Not To Proceed With a 
Rulemaking

AGENCY: Environmental Protection Agency (EPA).

ACTION: Petition; reasons for Agency response.

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SUMMARY: The Environmental Protection Agency (EPA or Agency) has 
decided not to proceed with the development of a regulation addressing 
the manufacture, processing, or distribution in commerce of lead for 
wheel-balancing weights (``lead wheel weights'') under the Toxic 
Substances Control Act (TSCA). This action relates to a citizen 
petition filed with the Agency in 2009 (``2009 petition''). The 2009 
petition, which EPA granted, asked EPA to initiate a rulemaking 
proceeding to regulate the manufacturing, processing, or distribution 
in commerce of lead wheel weights. In 2023, the same parties filed a 
petition for a writ of mandamus (``mandamus petition'') that sought to 
compel EPA to initiate the rulemaking proceeding requested in the 2009 
petition. After reviewing the information submitted in response to an 
advance notice of proposed rulemaking (ANPRM) issued in April 2024 and 
EPA's technical analysis thereof, EPA has decided not to proceed with 
the development of a proposed rule. Addressing potential remaining 
exposures from lead continues to be a high priority for EPA, as 
reflected in EPA's announcement that ``Lead and Lead Compounds'' is on 
its list of candidate chemical substances currently being considered 
for future prioritization actions under TSCA.

DATES: This decision is effective December 23, 2024.

ADDRESSES: The docket for this action, identified by docket 
identification (ID) number EPA-HQ-OPPT-2024-0085, is available online 
at https://www.regulations.gov. Additional information about dockets 
generally, along with instructions for visiting the docket in-person, 
is available at https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: 
    Technical information: Sean Duenser, Existing Chemicals Risk 
Management Division (7404M), Office of Pollution Prevention and Toxics, 
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, 
DC 20460-0001; telephone number: (202) 343-9157; email address: 
[email protected].
    General information: The TSCA Hotline, ABVI-Goodwill, 422 South 
Clinton Ave., Rochester, NY 14620; email address: [email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    This action is directed to the public in general. It may be of 
interest to those who manufacture, process, distribute in commerce, 
use, or dispose of lead wheel weights, or their substitutes. The 
following list of North American Industrial Classification System 
(NAICS) codes is not intended to be exhaustive, but rather provides a 
guide to help readers determine whether this document applies to them. 
Potentially affected entities may include:
     Primary Smelting and Refining of Nonferrous Metal (except 
Copper and Aluminum) (NAICS code 331419);
     Secondary Smelting, Refining, and Alloying of Nonferrous 
Metal (except Copper and Aluminum) (NAICS code 331492);
     Lead die-castings, unfinished, manufacturing (NAICS code 
331523);
     Lead die-castings, unfinished, manufacturing (NAICS code 
331523);

[[Page 104487]]

     Automobile Manufacturing (NAICS code 336111);
     Light Truck and Utility Vehicle Manufacturing (NAICS code 
336112);
     Heavy Duty Truck Manufacturing (NAICS code 336120);
     All Other Motor Vehicles Parts Manufacturing (NAICS code 
336399);
     Motorcycle, Bicycle, and Parts Manufacturing (NAICS code 
336991);
     Automobile and Other Motor Vehicle Merchant Wholesalers 
(NAICS code 423110);
     Motor Vehicle Supplies and New Parts Merchant Wholesalers 
(NAICS code 423120);
     Tire and Tube Merchant Wholesalers (NAICS code 423130);
     Motor Vehicle Parts (Used) Merchant Wholesalers (NAICS 
code 423140);
     New Car Dealers (NAICS code 441110);
     Used Car Dealers (NAICS code 441120);
     Recreational Vehicle Dealers (NAICS code 441210);
     Motorcycle, Boat, and Other Motor Vehicle Dealers (NAICS 
code 441220);
     Automotive Parts and Accessories Stores (NAICS code 
441310);
     Tire Dealers (NAICS code 441320);
     General Automotive Repair (NAICS code 811111);
     Other Automotive Mechanical and Electrical Repair and 
Maintenance (NAICS code 811118);
     Automotive Oil Change and Lubrication Shops (NAICS code 
811191); and
     All Other Automotive Repair and Maintenance (NAICS code 
811198).
    If you have any questions regarding the applicability of this 
action, please consult the technical information contact listed under 
FOR FURTHER INFORMATION CONTACT.

B. What is the Agency's authority for taking this action?

    TSCA section 21, 15 U.S.C. 2620, allows citizens to petition EPA to 
initiate a rulemaking proceeding for the issuance, amendment, or repeal 
of a rule under TSCA sections 4, 6, or 8 or an order under TSCA 
sections 4 or 5(e) through (f). If EPA grants such a petition, the 
Agency must promptly commence an appropriate proceeding. In addition, 
under TSCA section 6(a), if EPA determines that the manufacture, 
processing, distribution in commerce, use, or disposal of a chemical 
substance presents an unreasonable risk to human health or the 
environment, it must ``apply one or more of the [TSCA section 6(a)] 
requirements . . . to the extent necessary so that the chemical 
substance . . . no longer presents such risk,'' which may range from 
prohibiting or otherwise restricting the manufacturing, processing, or 
distribution in commerce of the chemical substance (or a particular 
use), to commercial use requirements or disposal restrictions, to 
labeling and recordkeeping, among other requirements.

C. What action is the Agency taking?

    EPA is issuing this action to inform the public of its decision not 
to regulate the manufacture, processing, or distribution in commerce of 
lead for wheel-balancing weights (``lead wheel weights'') under TSCA. 
This action is limited to lead for lead wheel weights. EPA's actions to 
address ``lead and lead compounds'' more broadly are discussed in Unit 
IV.C. This action relates to a citizen petition filed with the Agency 
in 2009 under TSCA section 21, which asked EPA to initiate a TSCA 
rulemaking proceeding to regulate the manufacturing, processing, or 
distribution in commerce of lead wheel weights (Ref. 1). The 2009 
petition was filed by representatives of the following groups: Ecology 
Center, Sierra Club, Alliance for Healthy Homes, Center for 
Environmental Health, Environmental Health Watch, Coalition to End 
Childhood Lead Poisoning, United Parents Against Lead, Louisiana ACORN, 
Lead Technicians, Tulane University, Drexel School of Public Health, 
and one individual (collectively, ``Petitioners''). EPA granted this 
petition in 2009. In 2023, the same parties filed a petition for a writ 
of mandamus (``mandamus petition'') in the United States Court of 
Appeals for the Ninth Circuit: Ecology Center, et al. v. U.S. EPA, No. 
23-70158 (9th Cir.) (Ref. 2). The mandamus petition sought to compel 
EPA to initiate the rulemaking proceeding requested in the 2009 
petition. EPA published for comment a proposed settlement agreement 
with the petitioners in March 2024. As part of the settlement 
agreement, EPA proceeded with an ANPRM in April 2024. EPA and the 
Petitioners then entered into a settlement agreement in September 2024.
    EPA is taking this action after reviewing the information submitted 
to EPA in response to the ANPRM (Ref. 3), in addition to other 
reasonably available information, and this action is also supported by 
EPA's technical analysis, entitled: Technical Support Document for Lead 
Wheel Weights (TSD) (Ref. 4), which further discusses the low potential 
for exposure to children and injury to human health or the environment 
from lead wheel weights based on the exposure scenarios evaluated for 
this petition.
    This action serves as EPA's final decision in response to the 2009 
petition. In addition, this action will not have a preemptive effect on 
State actions under TSCA section 18.

D. Why is the Agency taking this action?

    In April 2024, EPA published an ANPRM seeking information regarding 
the use and exposure to lead from the manufacture (including import), 
processing (including recycling), distribution in commerce, use, and 
disposal of lead wheel weights, as well as information on their 
substitutes, to help determine if there is unreasonable risk to human 
health and the environment associated with lead wheel weights (Ref. 3). 
The Agency received 128 comments providing input on whether to move 
forward with the development of a rule regulating lead wheel weights. 
The Agency did not, however, receive any lead wheel weight exposure 
data during the ANPRM public comment period that it had not already 
considered or that would be sufficient to determine that this activity 
presents an unreasonable risk of injury to health or the environment 
and necessitate a proposed rulemaking, as discussed in Unit IV. As also 
addressed in Unit IV., the Agency preliminarily found that risk 
associated with residential exposure is lower than previously believed. 
The Agency further believes that examination of risks associated with 
exposures to lead from the manufacture (including import), processing 
(including recycling), distribution in commerce, use, and disposal of 
lead wheel weights would be more appropriately assessed and addressed 
as part of a broader assessment of exposures associated with lead and 
lead compounds during a complete TSCA section 6(b) risk evaluation. 
Therefore, EPA is not proceeding with a proposed regulation addressing 
lead wheel weights.

II. Background

A. Overview of Lead Wheel Weights

    Wheel weights are small pieces of metal or other material used to 
correct imbalances in the weight distribution of motor vehicle tires. 
Lead has historically been a primary component of many wheel weights 
because of its malleability, high density, and relatively low cost. 
Nine States in the United States have banned the sale, distribution, 
and/or use of lead wheel weights. In addition, many automotive 
manufacturers, both those manufacturing within the United States

[[Page 104488]]

and those exporting vehicles to the United States, have switched to 
alternative wheel weight options in new vehicle production that meet 
the regulatory requirements in those states, citing the impracticality 
of using different wheel weights for new vehicles sold only in those 
States, due to the interstate and international nature of automotive 
production (Ref. 5). For the same reasons, most automotive 
manufacturers that sell vehicles in the United States are in compliance 
with Canada's prohibition on the use of lead wheel weights as well 
(Ref. 5). However, lead wheel weights may still be used for wheel 
balancing in auto repair and maintenance of vehicles post-sale. EPA 
identified one remaining domestic manufacturer of lead wheel weights in 
the United States and EPA has identified multiple importers of lead 
wheel weights (Ref. 6). Wheel weights can separate from the wheel due 
to failure of the adhesive or clip attaching them, or due to impact of 
the wheel with a pothole or road debris, during a crash, or due to 
other physical strains. Lead wheel weights that separate from vehicle 
wheels, or are not properly disposed of, may be abraded into fine 
particles by traffic. Abraded lead particles may then be released into 
the air as part of roadway dust due to turbulence from wind or from 
passing vehicles. As this lead migrates to nearby homes, it can enter 
the yard soil or the indoor dust. Children or adults living nearby can 
be exposed through ingestion of soil or dust particles. Lead wheel 
weights may also enter the environment by washing off roads during 
rain, being thrown from the road intact by vehicles, or by being 
collected by street cleaners and disposed of in landfills. Exposure 
scenarios identified by Petitioners are addressed further in the TSD 
(Ref. 4).

B. Overview of Petitioners Request

1. 2009 Petition
    In May 2009, Petitioners submitted a TSCA section 21 petition 
requesting that EPA ``establish regulations prohibiting the 
manufacture, processing, and distribution in commerce of lead wheel 
balancing weights (`wheel weights')'' (Ref. 1). Petitioners raised 
concerns that lead wheel weights result in pervasive lead exposure to 
children and health effects on ecological receptors. EPA requested 
public comment on the petition in July 2009 (Ref. 7) and granted the 
petition on August 26, 2009 (Ref. 8). EPA stated in its letter granting 
the petition, ``[t]he Agency will promptly commence an appropriate 
proceeding under TSCA. EPA anticipates commencing this proceeding 
through either an Advance Notice of Proposed Rulemaking or a Proposed 
Rule'' (Ref. 8).
2. 2023 Petition for Writ of Mandamus
    In August 2023, the same Petitioners sought a writ of mandamus in 
the United States Court of Appeals for the Ninth Circuit and asked the 
court to direct EPA to conclude the rulemaking Petitioners requested in 
the 2009 petition. EPA and Petitioners subsequently entered the Ninth 
Circuit Mediation Program. A joint motion to dismiss the petition for 
writ of mandamus was filed and granted. EPA was required to either (1) 
sign a proposed rule and request publication by the Office of the 
Federal Register, or (2) request publication in the Federal Register of 
a determination not to proceed with regulating lead wheel weights.
3. What support did the petitioners offer?
    In the 2009 petition, Petitioners highlighted that automobiles are 
a significant contributor to ongoing lead releases to the environment 
and identified lead wheel weight failures as one of the largest ongoing 
releases of lead to the environment (Ref. 1). Petitioners cited 
research from the New Jersey Department of Environmental Protection 
finding that high concentrations of environmental lead are directly 
correlated with traffic volume. Petitioners also claimed that the 
voluntary National Lead-Free Wheel Weight Initiative (NLFWWI) falls 
short of what is needed to protect children, the public, and the 
environment given EPA acknowledged that 1.6 million pounds of lead is 
lost when wheel weights fall off during normal driving conditions.
    EPA granted the 2009 petition on August 26, 2009. In the 2023 
mandamus petition, the Petitioners provided discussion on the danger 
posed by lead, stating that lead is a toxic heavy metal for which there 
is no safe level of exposure, citing EPA's own Integrated Science 
Assessment for Lead from 2013 (Ref. 9), and the Reconsideration of the 
Dust-Lead Hazard Standards and Dust-Lead Post Abatement Clearance 
Levels proposed rule (Ref. 10). Petitioners also discussed the impacts 
on human health and the environment related to lead exposures, 
stressing that children are at particularly high risk of harm from lead 
exposure (Ref. 2). Specifically, Petitioners noted that children 
experiencing disproportionate impacts due to racial and socioeconomic 
disparities are at high risk of harm. Petitioners also noted that lead 
causes detrimental environmental effects to fish and wildlife (Ref. 2). 
Petitioners raised that lead from lead wheel weights is one pathway of 
exposure to humans, claiming that lead wheel weights enter the 
environment, and ultimately people's bodies when they are dislodged 
from vehicles, despite the availability of safer, lead-free, wheel 
weight alternatives in the market (Ref. 2). Petitioners also provided 
comment and numerous studies in response to the ANPRM; however, no new 
information that could be used to inform exposure to lead wheel weights 
was identified in the comments.

C. Overview of the 2024 ANPRM

    In order for EPA to consider lead wheel weight regulation under 
TSCA section 6(a), the agency needs technical data linking lead wheel 
weight exposure to effects on human health and the environment in order 
to inform whether lead wheel weights pose unreasonable risk. EPA issued 
an ANPRM on April 3, 2024, requesting comment and information from the 
public and all stakeholders on the use and exposure to lead from the 
manufacture (including import), processing, distribution in commerce, 
use, and disposal of lead wheel weights, as well as information on 
their substitutes (Ref. 3). EPA received 21,297 comments, of which 128 
were posted to the docket, including 8 unique comments from 
Petitioners; mass mailers; comments from the recycling, metal, and 
automotive industries; and a scientific organization (Ref. 11). The 
Agency did not receive additional data in response to the ANPRM that 
could be used in its technical analysis to support a proposed 
rulemaking.
1. ANPRM Comment Summary
    The following is a summary of comments received on EPA's ANPRM for 
lead wheel weights (Ref. 3). This is intended to serve as a summary, 
rather than an opportunity for EPA to respond to each individual 
comment.
a. Lead Wheel Weight Effects on Human Health and the Environment
    Petitioners and advocacy groups support regulatory action for lead 
wheel weights based on the rationale that this would protect children's 
health (Ref. 12). Petitioners stated that fallen lead wheel weights can 
lead to potential exposures to children and adults who inhale or ingest 
roadway particles containing lead from wheel weights or who drink 
contaminated water (Ref. 12). They commented that even very low blood 
lead levels are associated with

[[Page 104489]]

neurodevelopmental harm with irreversible effects in children and 
increased risks of cardiovascular disease in adults (Ref. 12). Another 
commenter stated that scientists now recognize that lead does lasting 
harm to children even at extremely low exposure levels. The commenter 
cited the 2012 National Toxicology Program conclusion that blood lead 
concentrations below 5 [micro]g/dL have adverse effects on academic 
achievement, IQ, and attention-related behaviors (Ref. 13).
    The commenter added that people from backgrounds with socioeconomic 
disparities live closer to transportation roadways and are more 
vulnerable to exposure to lead wheel weights that have fallen from 
vehicles. The commenter stated that exposure to lead from the degraded 
wheel weights can occur in a variety of ways, including from 
pedestrians in urban areas (and their pets) stepping on dust from lead 
wheel weights in city streets and tracking the lead dust into their 
homes (Ref. 13). The commenter also noted that it is known that blood 
lead levels correlate with transportation corridors (both in and 
outside of urban centers) and lead wheel weights contribute to those 
transportation-related exposures. The commenter raised the concern that 
there is growing evidence that the adverse effects of lead are most 
severe in Black and Hispanic children and children in low-income 
households. The commenter contended that this suggests that 
socioeconomic disadvantages can worsen the impact of lead exposures 
(Ref. 13).
b. Safer Wheel Weight Alternatives and Voluntary Programs
    Petitioners also commented that there are widely available, 
economically viable alternatives to lead wheel weights (Ref. 12). 
Another commenter noted that industry has largely shifted into using 
zinc or steel alloy wheel weights (Ref. 5). The commenter continued to 
discuss that lead content in wheel weights has been reduced from the 
over 90% associated with high-density lead wheel weights to the current 
0.1% associated with current weights as mandated by multiple State and 
international standards. EPA's voluntary NLFWWI, combined with the 
actions taken by the States, has resulted in the voluntary removal of 
all but trace amounts of lead in wheel weights used in new vehicles 
manufactured by NLFWWI members. The commenter stated that this approach 
appears to have mitigated the potential for unreasonable risk to human 
health or the environment (Ref. 5).
c. State Bans on Lead Wheel Weights
    Petitioners are seeking a nationwide ban on lead wheel weights to 
streamline regulations and certainty across the United States. In their 
comments, Petitioners noted that even though there are existing lead 
wheel weight bans in nine States, Petitioners believe Federal action is 
required since they claim State bans are incomplete. For example, it is 
possible to live in a State where lead wheel weights are banned, such 
as Maine, and purchase lead wheel weights from online retailers such as 
eBay (Ref. 12). All State bans took place after the 2009 petition was 
granted. Another commenter, a trade association representing the auto 
industry, countered this assertion by stating that, given the 
interstate and international nature of auto production, it would be 
impractical to use different wheel weights for new vehicles sold in 
only those nine States. Consequently, the commenter noted, all of the 
automobile manufacturers in the trade association have switched to 
alternative wheel weight options in new vehicle production that meet 
the requirements of these State regulations (Ref. 5). The commenter 
extended this rationale internationally to Canada, where the country 
prohibited the ``manufacturing or importing wheel weights containing 
more than 0.1% lead by weight,'' in February 2024 (Ref. 14). The 
commenter noted that, for the same reasons, the original equipment 
manufacturer members that sell vehicles in the United States are in 
compliance with Canada's prohibition on the use of lead wheel weights 
(Ref. 5).
d. Federal Regulations on Lead Wheel Weight Recycling Already Exist
    One commenter expressed concerns about lead from wheel weights 
entering a metal scrap stream. The commenter feared that if the lead 
wheel weights are not removed prior to the shredding and crushing 
process, they become nearly impossible to locate within the scrap 
stream and will be melted in an electric arc furnace (EAF) (Ref. 15). 
However, another commenter believed existing regulations suffice, 
asserting that regulations for certain EAFs and iron and steel 
foundries under the Clean Air Act (CAA) effectively require removal of 
lead wheel weights from end-of-life vehicles (ELVs) by automotive 
dismantlers and metal shredding facilities. The commenter cited 
existing Federal regulations such as the CAA regulations under 40 CFR 
part 63, subparts EEEEE (Iron and Steel Foundries), YYYYY (Electric Arc 
Furnace Area Sources), and ZZZZZ (Iron and Steel Foundries Area 
Sources), which include requirements for these EAFs and foundries to 
minimize, to the extent practicable, the presence of lead and lead 
containing components in the input ferrous materials supplied to them 
(Ref. 16).
e. Economic Value and Obligations To Remove Lead Wheel Weights During 
Recovery and Recycling
    Multiple commenters also raised the economic value of recovering 
lead wheel weights at the recycling stage. One commenter mentioned that 
these recycling facilities are heavily regulated under Federal 
environmental statutes. The commenter believed that this ensures that 
recycling facilities have not just a legal obligation to properly 
manage any lead wheel weights, but also appropriate financial assurance 
for the future (Ref. 17). Another commenter provided an example of 
economic value to the recycling sector, commenting that lead wheel 
weights are easily accessible on the wheels of ELVs and are relatively 
valuable, especially as a recycled material that meets the ``ropes'' 
specification. The commenter believed that the low cost of removing 
lead wheel weights from the wheels of ELVs combined with their higher 
value provides economic incentive to remove them from ELVs as soon as 
possible (before further dismantling or shredding). Such removal of 
lead wheel weights prior to ELV shredding also provides operational 
benefits at the metal shredding facility (e.g., higher quality of 
produced recycled ferrous metal and recycled nonferrous metals) (Ref. 
16).
2. Additional Industry and Stakeholder Engagement
    In addition to issuing the ANPRM, EPA conducted outreach to various 
stakeholders in the lead wheel weight industry. EPA identified one 
remaining lead wheel weight manufacturer in the United States; other 
manufacturers that had previously manufactured lead wheel weights 
confirmed their transition to lead-free alternatives, such as steel and 
zinc alloy wheel weights, citing the bans of lead wheel weights in nine 
States. During discussions with the sole remaining manufacturer and 
other stakeholders, as well as review of comments to the ANPRM, EPA 
learned that lead wheel weight products are increasingly being imported 
into the United States rather than manufactured domestically. EPA 
requested exposure data from the manufacturer and did not receive any. 
The Alliance for Automotive Innovation, which represents automakers 
that produce and

[[Page 104490]]

sell approximately 95 percent of the new light-duty vehicles in the 
United States, commented that they surveyed their members and found 
that none of their original-equipment manufacturers use lead wheel 
weights on new vehicles manufactured or distributed to dealerships in 
the United States (Ref. 5).

III. Analysis of Exposure Pathways

A. Children's Roadside Exposure

    EPA analyzed the potential exposure pathway of residential exposure 
to children from lead-containing road dust from lead wheel weights. IQ 
loss in children is considered the most sensitive endpoint for lead 
exposure. This quantitative exposure analysis simulated the scenario 
for exposure from this pathway (a residence at the intersection of two 
busy roads) and estimated the blood lead levels and IQ decrement in 
children up to age 7 that could result from exposure to lead dust 
created by abraded lead wheel weights that could be tracked-in with 
yard soil or blown into a household where children could be exposed 
(Ref. 4). This analysis found low risk to children from this pathway 
based on the information and data available. The increase in 
residential soil and dust lead concentration due to lead wheel weights, 
even in the near-roadway scenario, is small compared with other sources 
that contribute to lead concentration. Soil and dust lead 
concentrations from lead wheel weights, along with residential 
background soil and dust lead concentrations taken from the American 
Healthy Homes Surveys (AHHS I and II), are presented in table 4-8 of 
the Technical Support Document (Ref. 4). The baseline concentrations of 
lead in residential soil and dust from the AHHS used in this analysis 
were 100.06 [mu]g/g and 79.16 [mu]g/g respectively, and lead wheel 
weights contributed an additional 3.02 [mu]g/g and 1.15 [mu]g/g 
respectively in the near-roadway scenario. The small contribution of 
lead wheel weights to residential lead concentrations leads to small 
potential impacts on BLL and IQ loss. The approximate wheel weight 
contribution to IQ point decrement was estimated to be 0.026 IQ points 
at the higher-end of predicted soil and dust exposure, which 
corresponded to a 2-year-old child living near a busy road 
intersection. By comparison, the estimated IQ decrement for a 2-year-
old child in the corresponding baseline scenario from residential 
background concentrations of lead in soil and dust was 2.61 IQ points 
(see table 5-2 in the Technical Support Document (Ref.4)). This means 
that the estimated IQ decrement from residential background 
concentrations of lead in soil and dust are over 100 times higher than 
those expected from lead wheel weight exposure for a 2-year-old child 
in the near-roadway scenario.
    In the children's roadside exposure scenario, lead wheel weights 
are lost from cars onto the road. Lost wheel weights are abraded over 
time due to weathering and further traffic abrasion. Some of the lead 
that is abraded will be emitted to the air as part of roadway dust due 
to roadway turbulence and other dust emission mechanisms. EPA estimated 
the road dust from lead wheel weights, accounting for the following 
parameters: loss rate of lead wheel weights, fraction of weights 
degraded per day, street cleaning frequency, additional wheel weight 
removal rate, additional dust loss rate, and emission rate. EPA used a 
similar model to characterize deposition to soil resulting from 
airborne lead particles emitted from the road, which computed the 
steady State amount of lead in the air as a function of distance away 
from the road. This model accounted for particle deposition rate, 
height of the air compartment, and wind speed. For its yard soil 
module, EPA predicted the yard lead concentrations in a receptor yard 
near the roadway, downwind from the road, which accounted for soil 
depth, half-life of lead in soil, dimensions of the yard, and 
accumulation time. Further modeling estimated the contribution of lead 
in yard soil from lead wheel weights to indoor dust lead concentrations 
in the residence. Each of these model parameters is subject to 
uncertainty, and, while EPA attempted to make conservative assumptions, 
when possible, not all exposure scenarios could be accounted for. For 
details of the assumptions made in estimating children's exposure to 
lead from lead wheel weights, please see the accompanying Technical 
Support Document (Ref. 4).
    EPA determined the effect of lead wheel weights on a hypothetical 
child's blood lead level using peer-reviewed models and literature 
wherever possible, using approaches and input values similar to those 
used in other EPA lead analyses. EPA's blood lead module used the lead 
soil, air, and dust concentrations as calculated above as inputs to the 
All Ages Lead Model (AALM) version 3.0, an EPA-developed exposure model 
of lead across a lifetime. Using this model, blood lead levels were 
estimated each year at ages 1 through 7. The results show a low impact 
of the exposure to lead wheel weights on blood lead levels through the 
first seven years of a child's life. Estimated exposure to lead wheel 
weights contributed to an increase of blood lead levels of 0.012 [mu]g/
dL at the higher end of the predicted exposure. That estimate means the 
contribution of lead exposure from lead wheel weights led to a less 
than 1% estimated increase in blood lead levels. Additionally, EPA 
calculated IQ decrements for children exposed to lead wheel weights in 
the children's roadside exposure scenario. The effects of lead wheel 
weights on lifetime IQ loss were estimated to be small (0.026 IQ points 
at the higher-end of predicted exposure) for the near-roadway soil and 
dust exposure scenario, and because IQ loss in children is considered 
the most sensitive endpoint for lead exposure, other health effects of 
near-roadway lead wheel weight exposure in children and adults were not 
evaluated, but are expected to be small as well.

B. Ecological Screening Assessment

    EPA considered lead wheel weights that are lost from cars and 
deposited into streams or freshwater lakes via rainfall by modeling a 
short-term exposure scenario and a long-term exposure scenario. In the 
short-term exposure scenario, a hypothetical 1-mile roadway drains 
directly into a stream after a 1-day rainfall event. The rate of lead 
wheel weight loss from cars on all modeled roads in the water 
deposition scenario was set to the highest value available in the 
scientific literature, representing a busy six-lane road in 
Albuquerque, New Mexico (Ref. 18) and corresponding to approximately 
five hundred 1-ounce lead wheel weights lost per mile of roadway per 
year. EPA expects that this assumption is an overestimate, as most 
roads are not six-lane highways and because current rates of lead wheel 
weight use are expected to be lower than in 2000, when the Albuquerque 
loss rate study (Ref. 18) was published. Nine U.S. States have banned 
lead wheel weights since this loss rate study was conducted, and an 
industry group representing the manufacturers of approximately 95 
percent of new cars sold in the United States currently indicates that 
these manufacturers no longer use lead wheel weights on new vehicles 
(Ref. 5). Aquatic organisms in streams and lakes can be exposed to lead 
through this route. EPA's assessment of this scenario estimates the 
lead concentration in water attributable to lead wheel weights that 
dissolve in streams and lakes. It considers a 1-day rainfall event and 
long-term accumulation of lead wheel weights in freshwater bodies.
    This assessment accounted for the following parameters: wheel 
weight loss

[[Page 104491]]

rate, street cleaning frequency, flow rate of stormwater-receiving 
streams, fraction of lead wheel weights that dissolve during each 
rainfall event, and water concentrations. EPA assumed that all lead 
wheel weights present on the roadway were washed into the stream, that 
no rainfall event had occurred since the street was last cleaned, and 
that the maximum time had elapsed between street cleaning events (6 
months). These assumptions corresponded to slightly more than 257 1-
ounce lead wheel weights simulated to enter the 1-mile stretch of 
stream. EPA estimated lead concentrations for varying values of 
streamflow and dissolution rates of lead in a 1-day rainfall scenario. 
The maximum water concentration attributable to lead wheel weights due 
to a 1-day rainfall event is 0.0000164 [mu]g/L (less than 0.1 parts per 
trillion), which occurs when 100% of a lead wheel weight dissolves per 
year (the fastest dissolution rate modeled), there are only two 
rainfall events per year, each immediately preceding the street 
cleaning event (leading to the maximum possible accumulation of lead 
wheel weights), and the stream flow rate is 50 cubic feet per second 
(the smallest stream modeled). By comparison, the level of concern for 
acute freshwater aquatic exposure to lead in water is 65 [mu]g/L (Ref. 
19). Therefore, under the most conservative conditions modeled (a fast 
dissolution rate for lead wheel weights, and a small stream containing 
a low volume of water in which to dilute the wheel weights' lead 
contribution), the estimated water concentration of lead attributable 
to wheel weights remains far below the level of concern for acute 
toxicity in freshwater organisms. The slow dissolution rate of lead 
wheel weights and the relative insolubility of inorganic lead in water 
means that the estimated acute exposure to lead in freshwater streams 
due to lead wheel weights (0.0000164 [mu]g/L) is far below the acute 
level of concern for aquatic life (65 [mu]g/L), indicating that acute 
toxicity to freshwater organisms from lead wheel weights is unlikely 
based on this analysis.
    EPA also considered a long-term ecological exposure scenario. 
Depending on certain conditions (e.g., water acidity), lead wheel 
weights that have been swept up by rainfall and deposited in freshwater 
ponds and lakes can dissolve over time, increasing the lead water 
concentration. EPA's analysis of this scenario considers the average 
contribution of lead wheel weights to freshwater lead concentration on 
a national scale. The model was based on determining the accumulated 
mass of wheel weights in water, the rate at which they dissolve, the 
volume of water, and the rate at which fresh water is replaced by 
rainfall. This analysis determined that the highest estimated lead 
concentration in water was 0.0009 [mu]g/L (less than 1 part per 
trillion), which is below the criterion continuous concentration (CCC) 
hazard level for freshwater aquatic life, which ranges from 1.3 to 7.7 
[mu]g/L depending on water hardness with a default value at 2.5 [mu]g/L 
(corresponding to 100 mg/L hardness as CaCO3). This estimate 
included the assumption that 100 percent of lost lead wheel weights are 
deposited in water bodies. Therefore, actual average lead 
concentrations in the environment due to lead wheel weights are likely 
lower, although limitations in the analysis due to the national scale 
of the long-term ecological exposure scenario means that individual 
water bodies may experience different contributions of lead from lead 
wheel weights depending on their location relative to roads. For 
further details on the technical analyses conducted in support of this 
action, please see the accompanying Technical Support Document.

IV. Decision Not To Proceed With Rulemaking

A. EPA's Analysis Estimates Low Impacts to Children and the Environment 
From Exposure to Lead Wheel Weights

    Children exposed to lead are at an increased risk of adverse health 
effects, including decreased cognitive performance, greater incidence 
of problem behaviors, and increased diagnoses of attention-related 
behavioral problems. The negative health effects associated with lead 
exposure are well-documented, and include neurological, cardiovascular, 
renal, reproductive, developmental, and hematological effects (Ref. 
20). Several studies have demonstrated a link between increased blood 
lead level (BLL) and IQ loss in children (Ref. 21 and Ref. 22). IQ loss 
is among the most sensitive endpoints studied (i.e., IQ loss occurs at 
a lower BLL than other health effects and therefore IQ loss is used as 
a reference for lead's adverse health effects in children). EPA 
calculated IQ decrements for children exposed to lead from lead wheel 
weights in a near-roadway scenario, where lead is released into the 
roadway environment due to abrasion of lost wheel weights, the lead 
migrates to the air surrounding the home, the deposition of lead 
particles contributes to yard soil concentrations, and outdoor soil 
lead levels influence the indoor dust lead levels in the residence 
(Ref. 4). The effects of lead wheel weights on lifetime IQ loss were 
estimated to be low for the near-roadway soil and dust scenario. At 
ages 2 and 7, lifetime IQ loss models with conservative assumptions 
found the contribution of lead wheel weights to result in an estimated 
difference in lifetime IQ loss of 0.026 points for this exposure 
scenario. This means that near-roadway soil and dust exposure from 
abraded lead wheel weights added approximately 1 percent to the IQ loss 
already attributable to exposure to other sources of lead.
    Lead exposure can also cause adverse effects in animals and plants 
in the environment (Ref. 20). EPA estimated water concentrations in 
streams and water bodies attributable to lead wheel weights lost from 
vehicles and compared them to the freshwater levels of concern 
published in the Ambient Water Quality Criteria for Lead (Ref. 19). 
These levels of concern represent acute and chronic lead concentrations 
in freshwater that EPA considers harmful to wildlife. In the acute 
(short-term) and chronic (long-term) scenario, EPA's analysis estimated 
that the concentration of lead in freshwater streams and water bodies 
attributable to lead wheel weights was less than 1 part per trillion. 
By comparison, the freshwater levels of concern are 65 parts per 
billion for acute exposure, and 2.5 parts per billion for chronic 
exposure. The estimated lead exposure of wildlife in freshwater due to 
lead wheel weights is several orders of magnitude lower than the acute 
and chronic levels of concern, indicating low potential for adverse 
effects. See EPA's TSD for more information (Ref. 4).
    In addition to the conclusions made in EPA's analysis, the Agency 
did not receive, during its engagement with stakeholders and with the 
sole remaining domestic lead wheel weight manufacturer, or during the 
30-day public comment period for the ANPRM, additional data that could 
be used in the TSD that would support a proposed rulemaking for lead 
wheel weights. The Agency did receive comment from the Alliance for 
Automotive Innovation, which represents automakers that produce and 
sell approximately 95 percent of the new light-duty vehicles in the 
United States. They surveyed their members and found that none of their 
original-equipment manufacturers use lead wheel weights on new vehicles 
manufactured or distributed to dealerships in the United States (Ref. 
5).

B. Statutory and Regulatory Context

    In the August 2023 mandamus petition (Ref. 2), Petitioners cite 
EPA's

[[Page 104492]]

proposed rule entitled, ``Reconsideration of the Dust-Lead Hazard 
Standards and Dust-Lead Post-Abatement Clearance Levels'' (88 FR 50444, 
August 1, 2023 (FRL-8524-01-OCSPP)) (Ref. 10). Specifically, 
Petitioners reference EPA's statement: ``[T]here is no evidence of a 
threshold below which there are no harmful health effects from lead 
exposure.'' This is cited to support the petition's discussion on the 
dangers posed by lead and lead wheel weights and, more specifically, 
that lead is a dangerous toxic chemical that can cause irreversible 
health harms at low levels of exposure. Furthermore, the Federal Lead 
Action Plan, developed by the President's Task Force on Environmental 
Health Risks and Safety Risks to Children, which comprises 17 Federal 
departments and offices, including EPA, states that ``no safe blood 
lead level in children has been identified'' (Ref. 23).
    EPA is reaffirming these positions and continues its commitment to 
strengthening public health protections, addressing lead contamination 
for communities with the greatest exposures, and promoting 
environmental justice. EPA is clarifying in this document that the 
authorities under Title X of the Housing and Community Development Act 
of 1992 (also known as the Residential Lead-Based Paint Hazard 
Reduction Act of 1992 or ``Title X'') (Pub. L. 102-550) and TSCA Title 
IV differ from TSCA section 6.
    TSCA Title IV directs EPA to identify the level of dust-lead 
exposure that ``would result in adverse human health effects'' as a 
type of lead-based paint hazard (15 U.S.C. 2681(10)). In addition, on 
May 14, 2021, the United States Court of Appeals for the Ninth Circuit 
issued an opinion (2021 Court Opinion) which instructed EPA to consider 
only health factors when setting the dust-lead hazard standards 
(described as ``dust-lead reportable levels'' in EPA's final rule) (89 
FR 89416, November 12, 2024 (FRL-8524-02-OCSPP)). On November 12, 2024, 
EPA published the final rule to lower these standards to ``any 
reportable level as analyzed by a laboratory recognized by EPA's 
National Lead Laboratory Accreditation Program (NLLAP).'' This revision 
acknowledges the current state of scientific evidence (i.e., that there 
is no evidence of a threshold below which there are no harmful effects 
on cognition from lead exposure) and is consistent with the 2021 Court 
Opinion. The revised hazard standards are inclusive of any reportable 
level of dust-lead and do not distinguish based on health risks posed. 
In the same rule, EPA revised the dust-lead action levels (DLAL, 
previously known as dust-lead clearance levels), which are the 
allowable levels of dust-lead loadings on a surface following 
completion of an abatement activity outlined in the Lead-based Paint 
Activities Rule (40 CFR 745.83 and 745.223). The revised DLAL are 5 
[mu]g/ft\2\, 40 [mu]g/ft\2\, and 100 [mu]g/ft\2\ for floors, window 
sills, and troughs, respectively, and are the levels at which EPA 
recommends an abatement or other lead hazard control measures. 
Therefore, under the Lead-based Paint Activities Rule, in instances 
where reportable dust-lead levels are present (i.e., a dust-lead 
hazard), EPA recommends lead hazard control work only when the levels 
are at or above the DLAL.
    Under TSCA section 6(a), ``[i]f the Administrator determines in 
accordance with subsection (b)(4)(A) that the manufacture, processing, 
distribution in commerce, use or disposal of a chemical substance or 
mixture, or that any combination of such activities, presents an 
unreasonable risk of injury to health or the environment, the 
Administrator shall by rule . . . apply one or more of the [section 
6(a)] requirements to such substance or mixture to the extent necessary 
so that the chemical substance no longer presents such risk.'' EPA 
looks to section 6(b) and its implementing regulations (Ref. 24) when 
considering whether a chemical substance presents an unreasonable risk. 
Pursuant to TSCA section 6(b), EPA must decide whether the ``chemical 
substance presents an unreasonable risk of injury to health or the 
environment, without consideration of costs or other non-risk factors, 
including an unreasonable risk to potentially exposed or susceptible 
subpopulations identified as relevant to the risk evaluation by the 
Administrator, under the conditions of use.'' For example, TSCA section 
6(b)(4)(F) states: ``In conducting a risk evaluation under this 
subsection, the Administrator shall . . . integrate and assess 
available information on hazards and exposures for the conditions of 
use of the chemical substance.'' When determining unreasonable risk, 
the Agency weighs the effects of the chemical substance on health and 
human exposure under the conditions of use; the effects of the chemical 
substance on the environment and environmental exposure under the 
conditions of use; the population exposed (including any potentially 
exposed or susceptible subpopulations), the severity of hazard (the 
nature of the hazard, the irreversibility of hazard), and 
uncertainties.

C. Including Lead and Lead Compounds in the TSCA Prioritization Process

    EPA's work to protect children from exposure to lead is ongoing, 
and reducing childhood lead exposure continues to be a priority for 
both EPA and the Federal Government (Federal Lead Action Plan) (Ref. 
23). There are multiple sources of lead including lead-based paint, 
lead in drinking water, and lead contaminated dust and soil. As a part 
of this action, the Agency analyzed the potential risk from lead in the 
environment as a result of lead from fallen wheel weights, which could 
in turn contaminate residential soil, residential dust, surface water, 
and groundwater, as these risks were the focus of the 2009 petition. 
EPA recognizes there are many other potential sources of lead exposure, 
including occupational exposure during the production and processing of 
lead wheel weights. However, EPA believes these exposures would be more 
appropriately assessed when ``Lead and Lead Compounds'' are prioritized 
and a full risk evaluation under TSCA section 6(b) with peer review can 
be conducted. During this process, EPA will conduct a comprehensive, 
peer reviewed, risk evaluation to determine whether lead and lead 
compounds present an unreasonable risk of injury to health, without 
consideration of costs or other non-risk factors, including an 
unreasonable risk to potentially exposed or susceptible subpopulations 
identified. EPA will identify, where relevant, the likely duration, 
intensity, frequency, and number of exposures to lead and lead 
compounds under each condition of use for each step in the chemical's 
life cycle. EPA may also need to develop a peer-reviewed threshold to 
determine the level of adult health effects that would be considered 
unreasonable during the risk evaluation process.
    EPA has included ``Lead and Lead Compounds'' on its list of 
candidate chemical substances currently being considered for future 
prioritization actions. As described in 40 CFR 702.5(c)(2), EPA is 
required to ensure that, at any given time, at least 50 percent of TSCA 
risk evaluations are drawn from the TSCA 2014 Work Plan (Ref. 25). Lead 
and lead compounds are included in the TSCA 2014 Work Plan, but 
prioritization and risk evaluation for lead and lead compounds have not 
yet been initiated (Ref. 26). During a risk evaluation, lead and lead 
compounds would undergo a 3-year robust and comprehensive review of 
hazards and exposures and consider the weight of the scientific 
evidence as required by

[[Page 104493]]

TSCA section 6(b)(4)(F), including peer-review of scientific 
information, technical procedures, measures, methods, protocols, 
methodologies, or models used in the evaluation, employed in a manner 
consistent with the best available science, in accordance with TSCA 
section 26(h).

V. References

    The following is a list of the documents that are specifically 
referenced in this document. The docket includes these references and 
other information considered by EPA, including documents that are 
referenced within the documents that are included in the docket, even 
if the reference is not physically located in the docket. For 
assistance in locating these other documents, please consult the 
technical person listed under FOR FURTHER INFORMATION CONTACT.

1. Ecology Center. TSCA Section 21 Petition Requesting EPA to 
Establish Regulations Prohibiting the Manufacture, Processing, and 
Distribution in Commerce of Lead Wheel Balancing Weights. May 28, 
2009. https://www.epa.gov/sites/default/files/2015-10/documents/petition4.pdf.
2. United States Court of Appeals for the Ninth Circuit. Petition 
for Writ of Mandamus. August 22, 2023. https://www.epa.gov/system/files/documents/2024-01/petition-for-review.pdf.
3. U.S. EPA. Lead Wheel Weights; Regulatory Investigation Under the 
Toxic Substances Control Act (TSCA). Federal Register. 89 FR 22972, 
April 3, 2024 (FRL-5398-05-OCSPP). https://www.govinfo.gov/content/pkg/FR-2024-04-03/pdf/2024-06804.pdf.
4. U.S. EPA. Technical Support Document for Lead Wheel Weights. 
December 2024.
5. Comment submitted by Alliance for Automotive Innovation. May 9, 
2024. https://www.regulations.gov/comment/EPA-HQ-OPPT-2024-0085-0037.
6. Abt. Memo, Estimated Volume of LWW Imports, Manufacture, and Use. 
July 23, 2024.
7. U.S. EPA. Lead Wheel Balancing Weights; TSCA Section 21 Petition; 
Notice of Receipt and Request for Comment. Federal Register. 74 FR 
34342, July 15, 2009 (FRL-8424-7). https://www.govinfo.gov/content/pkg/FR-2009-07-15/pdf/E9-16815.pdf.
8. U.S. EPA. EPA Response to TSCA Section 21 Petition. August 26, 
2009. https://www.epa.gov/sites/default/files/2015-10/documents/document.pdf.
9. U.S. EPA. Integrated Science Assessment for Lead. July 2013. 
https://assessments.epa.gov/isa/document/&deid%3D255721.
10. U.S. EPA. Proposed rule. Reconsideration of the Dust-Lead Hazard 
Standards and Dust-Lead Post-Abatement Clearance Levels. Federal 
Register. 88 FR 50444, August 1, 2023 (FRL-8524-01-OCSPP). https://www.govinfo.gov/content/pkg/FR-2023-08-01/pdf/2023-15073.pdf.
11. U.S. EPA. Lead Wheel Weight Docket. https://www.regulations.gov/docket/EPA-HQ-OPPT-2024-0085.
12. Comment submitted by Ecology Center et al. May 10, 2024. https://www.regulations.gov/comment/EPA-HQ-OPPT-2024-0085-0058.
13. Comment submitted by Project TENDR (Targeting Environmental 
Neuro-Development Risks), The Arc of the U.S. May 9, 2024. https://www.regulations.gov/comment/EPA-HQ-OPPT-2024-0085-0039.
14. Canada Gazette. Prohibition of the Manufacture and Importation 
of Wheel Weights Containing Lead Regulations. Part II, Volume 157, 
Number 4. February 3, 2023. https://gazette.gc.ca/rp-pr/p2/2023/2023-02-15/html/sor-dors15-eng.html.
15. Comment submitted by Steel Manufacturers Association (SMA). May 
9, 2024. https://www.regulations.gov/comment/EPA-HQ-OPPT-2024-0085-0038.
16. Comment submitted by Recycled Materials Association (ReMA). May 
9, 2024. https://www.regulations.gov/comment/EPA-HQ-OPPT-2024-0085-0041.
17. Comment submitted by Association of Battery Recyclers, Inc. 
(ABR), Battery Council International (BCI), and International Lead 
Association (ILA). May 10, 2024. https://www.regulations.gov/comment/EPA-HQ-OPPT-2024-0085-0057.
18. Root RA. Lead loading of urban streets by motor vehicle wheel 
weights. Environ Health Perspect. 2000 Oct;108(10):937-40. doi: 
10.1289/ehp.00108937. PMID: 11049812; PMCID: PMC1240125.
19. U.S. EPA. Ambient Water Quality Criteria for Lead--1984. EPA-
400/5-84-027. Washington, DC: Office of Water, Regulations and 
Standards Criteria and Standards Division. January 1985.
20. U.S. EPA. Integrated Science Assessment for Lead. January 2024. 
https://assessments.epa.gov/isa/document/&deid%3D359536.
21. Lanphear et al. Low-level environmental lead exposure and 
children's intellectual function: an international pooled analysis. 
Environ Health Perspect. 2005 Jul;113(7):894-9. doi: 10.1289/
ehp.7688.
22. Lanphear et al. Erratum: Low-Level Environmental Lead Exposure 
and Children's Intellectual Function: An International Pooled 
Analysis. Environ Health Perspect. 2019 Sep;127(9):99001. doi: 
10.1289/EHP5685. PMID: 16002379; PMCID: PMC1257652.
23. President's Task Force on Environmental Health Risks and Safety 
Risks to Children. 2018. The Federal Action Plan to Reduce Childhood 
Lead Exposures and Associated Health Impacts. https://ptfcehs.niehs.nih.gov/sites/niehs-ptfceh/files/resources/lead_action_plan_508.pdf.
24. U.S. EPA. Procedures for Chemical Risk Evaluation Under the 
Toxic Substances Control Act (TSCA). Federal Register. 89 FR 37028, 
May 3, 2024 (FRL-8529-02-OCSPP). https://www.govinfo.gov/content/pkg/FR-2024-05-03/pdf/2024-09417.pdf.
25. U.S. EPA. TSCA Work Plan for Chemical Assessments: 2014 Update. 
October 2014. https://www.epa.gov/sites/default/files/2015-01/documents/tsca_work_plan_chemicals_2014_update-final.pdf.
26. U.S. EPA. 2012 TSCA Work Plan Chemicals. June 2012. https://www.epa.gov/sites/default/files/2014-02/documents/work_plan_chemicals_web_final.pdf.

    Authority: 15 U.S.C. 2601 et seq.

    Dated: December 16, 2024.
Michal Freedhoff,
Assistant Administrator, Office of Chemical Safety and Pollution 
Prevention.
[FR Doc. 2024-30401 Filed 12-20-24; 8:45 am]
BILLING CODE 6560-50-P
```